Senior Pharmacovigilance Scientist

Responsibilities Lead the signal management process, including signal detection, documentation, and safety risk decisions for assigned products Author signal evaluation reports and manage literature review for safety information Respond to safety questions from regulatory authorities and lead Aggregate Report management Finalize aggregate safety reports such as PSURs, DSURs, REMS, and RMPs for assigned products Collaborate with Global Safety Officers and Safety MDs on investigational programs, including clinical trial activities and safety committee management Manage data analysis, signal detection, and product activities as assigned Oversee and spearhead critical pharmacovigilance activities as a product lead within the Safety team Hire, train, and mentor staff dedicated to product-specific tasks Ensure compliance with global safety regulations and guidelines Foster data analysis and product information sharing across cross-functional teams Requirements Bachelor’s Degree in biologic or natural science, or health care discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required Significant and proven Pharmacovigilance experience, including aggregate safety reports and safety signal management Ability to interpret, analyze, and present scientific and medical data clearly Experience leading and conducting projects related to signaling and regulatory agency requests Strong foundation in Pharmacovigilance and drug development, including knowledge of safety regulations Proficiency in common data processing software (Excel, PowerPoint, Microsoft Word) Leadership skills and collaborative interaction in team environments, internally and externally Strong organizational skills with the ability to prioritize independently Knowledge of common safety database systems Experience interacting with cross-functional teams such as Clinical Development and Regulatory Core Competencies Demonstrates expertise in Pharmacovigilance, including signal management, safety report finalization, and compliance with global safety regulations. Proven ability to lead cross-functional teams and mentor staff while effectively analyzing and presenting scientific data. Highest-signal resume keywords Pharmacovigilance Experience Aggregate Safety Reports Signal Management Leadership Skills Data Analysis ATS Optimization Keywords Hard Skills Signal Detection Safety Risk Decisions Literature Review Safety Regulations Project Management Data Analysis Safety Database Systems Scientific Data Interpretation Drug Development Knowledge Regulatory Agency Interaction Soft Skills Organizational Skills Collaborative Interaction Mentoring Prioritization Certifications & Qualifications Bachelor’s Degree in Biologic or Natural Science Advanced Degree (PhD, MPH, NP, PharmD) Industry Keywords Pharmacovigilance Safety Information Clinical Trial Activities Aggregate Report Management PSURs DSURs REMS RMPs Global Safety Officers Cross-Functional Teams Tools & Technologies Excel PowerPoint Microsoft Word #J-18808-Ljbffr Jobtailor